Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma

NCT06822829 | Recruiting

• 1 other identifier: 446/2023/OSS/IRCCSRE
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce/ and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice. The goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma. More precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.

Conditions

Diffuse Large B Cell Lymphoma (DLBCL); Indolent B-Cell Lymphomas; Indolent B Cell Lymphoma

Keywords

indolent relapse; diffuse large b cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is calculated from the date of initiation of treatment for indolent lymphoma relapse to death from any cause or the last follow-up for censored cases.

  Up to 2 years

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to 2 years

• Response Rate

  Up to 2 years

• Adverse Events

  Up to 2 years

• Type of Therapy

  Up to 2 years

• Cause of Death

  Up to 2 years

Study Arms (1)

Patients diagnosed with diffuse large B-cell lymphoma

Retrospective cohort of patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who relapsed as indolent B-cell lymphoma between 2010 and 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be proposed to patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who have relapsed as indolent B-cell lymphoma, with a histologically confirmed diagnosis of relapse and availability of the histological report. Patients who are still alive will be contacted and informed by the specialist about the study's objectives and will be required to sign a specific informed consent form. For patients lost to follow-up or deceased, a waiver of informed consent has been obtained from the Ethics Committee in accordance with applicable regulations.

You may qualify if:

• Age 18 years or older at the time of diagnosis.
• Previous diagnosis of diffuse large B-cell lymphoma with/without a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.
• First-line treatment for diffuse large B-cell lymphoma.
• Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.
• Availability of the histological report of the relapse.
• Availability of clinical and laboratory data related to both the initial diagnosis and relapse.
• Availability of follow-up data.
• Consent to participate in the study and signing of the specific informed consent form (for living and/or contactable patients).

You may not qualify if:

• \- None

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Related Publications (2)

• Wang Y, Link BK, Witzig TE, Maurer MJ, Allmer C, King RL, Feldman AL, Habermann TM, Ansell SM, Slager SL, Cerhan JR, Nowakowski GS. Impact of concurrent indolent lymphoma on the clinical outcome of newly diagnosed diffuse large B-cell lymphoma. Blood. 2019 Oct 17;134(16):1289-1297. doi: 10.1182/blood.2019000858.

  PMID: 31350266 BACKGROUND

• Ghesquieres H, Berger F, Felman P, Callet-Bauchu E, Bryon PA, Traverse-Glehen A, Thieblemont C, Baseggio L, Michallet AS, Coiffier B, Salles G. Clinicopathologic characteristics and outcome of diffuse large B-cell lymphomas presenting with an associated low-grade component at diagnosis. J Clin Oncol. 2006 Nov 20;24(33):5234-41. doi: 10.1200/JCO.2006.07.5671. Epub 2006 Oct 16.

  PMID: 17043351 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Elena Nizzoli, MD

  Azienda USL - IRCCS di Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Attilio Gennaro, Clinical Research Coordinator

CONTACT

+39 0522 295175; attilio.gennaro@ausl.re.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: August 19, 2024
• Primary Completion: October 17, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)